tooluniverse-clinical-trial-protocol

tooluniverse-clinical-trial-protocol is a skill for Claude Code from mims-harvard/ToolUniverse. It costs 146 tokens per session (1,853 once invoked), scanned A, original, Apache-2.0.

A document generator for clinical trial protocols, the detailed plans that describe how a study of a drug or medical device will be run. It covers study goals, participants, treatment, measurements, safety monitoring, statistics, and sample-size reasoning using regulatory and trial references.

In plain words
What is it for?
Use it to draft a full protocol, an FDA-style study document, or the statistical analysis and sample-size sections for a clinical trial.
Why use it?
It turns an agreed trial concept into a structured protocol draft instead of requiring every section to be written from scratch. It is intended to follow an earlier feasibility and design assessment rather than replace that work.

Skill for Claude Code

Written for Claude Code: disable-model-invocation in frontmatter.

Part of the tooluniverse plugin — 162 skills, 8 commands, 1 agent, 1 hook, 1 MCP server shipped together

Good fit Use it to draft a full protocol, an FDA-style study document, or the statistical analysis and sample-size sections for a clinical trial.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-protocol
About the project

ToolUniverse is a collection of tools, interfaces, and supporting components for building AI systems that perform scientific work. It is for developers creating AI scientist agents that use APIs, databases, machine-learning tools, and domain-specific utilities. The catalogue includes skills, commands, an MCP server, an agent, and a hook for working with the ecosystem.

mims-harvard/ToolUniverse · 1,744 stars · on GitHub · aiscientist.tools

Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Any agent
npx skills add mims-harvard/ToolUniverse --skill tooluniverse-clinical-trial-protocol
Clone the repo
git clone --depth 1 https://github.com/mims-harvard/ToolUniverse

Made for: Claude Code.

Or install tooluniverse, the plugin that ships this one along with the rest of its 162 skills, 8 commands, 1 agent, 1 hook, 1 MCP server.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for tooluniverse-clinical-trial-protocol

README.md
[![agentmods](https://agentmods.dev/badge/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-protocol/github.svg)](https://agentmods.dev/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-protocol)
Your own site
<a href="https://agentmods.dev/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-protocol"><img src="https://agentmods.dev/badge/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-protocol/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

agentmods 80×15 button for tooluniverse-clinical-trial-protocol

Your own site · 80×15
<a href="https://agentmods.dev/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-protocol"><img src="https://agentmods.dev/badge/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-protocol.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 146 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 1,853 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5.1 $0.00146 $0.01853
Opus 5.5 $0.00058 $0.00741
Sonnet 5.5 $0.00029 $0.00371
Haiku 4.5 $0.00015 $0.00185

Measured 10d ago against content hash b8c5c6e8217a, method: parsed. Prices are Anthropic first-party input rates as of 2026-10-07, from the pricing page.

Security

Grade A, and why

tooluniverse-clinical-trial-protocol scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 10d ago.

The scan reads SKILL.md. This mod also ships 1 executable file (scripts/sample_size_calculator.py), listed below but not scanned — reading those needs a real analyzer, not pattern matching.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

plugin/skills/tooluniverse-clinical-trial-protocol/SKILL.md · 99 lines

How it starts

The opening of the file, as written. The whole thing — 99 lines — stays where its author put it; the contents beside it link to each section on GitHub.

Clinical Trial Protocol Generation

Turns a trial concept into an actual protocol DOCUMENT, grounded in real precedent-trial and regulatory-database lookups plus a genuine statistical sample-size calculation.

This skill is a downstream step, not a replacement for tooluniverse-clinical-trial-design. That skill answers "is this trial feasible, and what should endpoint/population/comparator/effect-size/duration/regulatory-pathway be?" (a 0-100 feasibility score with evidence grading). This skill takes those six answers — freshly run or already available from a prior tooluniverse-clinical-trial-design report — and drafts the actual protocol sections around them. Do not re-derive feasibility scoring, endpoint selection reasoning, or regulatory-pathway strategy here — call tooluniverse-clinical-trial-design for that and consume its output.

When to Use This Skill

  • "Write me a clinical trial protocol for [drug/device]"
  • "Generate an FDA submission protocol for our Phase 2 study"
  • "Draft the statistical analysis plan / sample size section"
  • "I have the feasibility assessment — now turn it into a protocol document"
  • "What sample size do I need for a [proportion/continuous/survival] endpoint?"

NOT for (use other skills instead)

  • Feasibility scoring, endpoint/population/comparator selection strategy -> tooluniverse-clinical-trial-design (run this FIRST if not already done)
  • Patient-to-trial matching for an individual patient -> tooluniverse-clinical-trial-matching
  • Drug mechanism / preclinical investigation -> tooluniverse-drug-research or tooluniverse-drug-mechanism-research
  • Jurisdiction-aware approval/exclusivity lookups outside the protocol context -> tooluniverse-drug-regulatory

Workflow

Step 1 — Confirm feasibility inputs exist

Ask the user (or check the conversation) whether a tooluniverse-clinical-trial-design feasibility report already exists for this indication/intervention.

  • If yes: reuse its 6-dimension findings directly (endpoint, population, comparator, effect size, duration, regulatory pathway, plus the evidence grades A-D).
  • If no: run tooluniverse-clinical-trial-design first. Do not guess these six answers yourself — that skill's precedent-based reasoning exists precisely so this step doesn't fabricate them.

Read the full file on GitHub · 99 lines

Files

What ships with it

4 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 10d ago First seen · 99 lines · 146 tokens per session scan A b8c5c6e8217a

Subscribe to this mod's changes

tooluniverse-clinical-trial-protocol is a skill published in the GitHub repository mims-harvard/ToolUniverse (1,744 stars, last pushed yesterday), licensed Apache-2.0. It adds 146 tokens to every session and 1,853 once invoked, about $0.0006 per session on Opus 5.5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-10-07.

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